FDA device listing
4.0MM CANNULATED CAPTURED SCREW 32MM Stainless Steel,4.0MM CANNULATED CAPTURED SCREW 34MM Stainless Stee,4.0MM…
FDA device listing 1631519127 · Smith & Nephew, Inc.
Key facts
| Proprietary names | 4.0MM CANNULATED CAPTURED SCREW 32MM Stainless Steel,4.0MM CANNULATED CAPTURED SCREW 34MM Stainless Stee,4.0MM CANNULATED CAPTURED SCREW 38MM Stainless Steel,4.0MM CANNULATED CAPTURED SCREW 42MM Stainless Steel,4.0MM CANNULATED CAPTURED SCREW 44MM Stainless Steel,4.0MM PARTIALLY THREADED CANNULATED SCREW 2.5 HEX SST 30MM,4.0MM PARTIALLY THREADED CANNULATED SCREW 2.5 HEX SST 32MM,4.0MM PARTIALLY… |
|---|---|
| Owner/operator | Smith & Nephew, Inc. |
| Owner/operator number | 1020279 |
| Premarket submissions | K133662 |
| Product codes | HWC |
| Device names | HWC - Screw, Fixation, Bone |
| Device class | Class II |
| Classification regulations (21 CFR) | 888.3040 |
| Review panels | Orthopedic |
| Registered establishments | Smith & Nephew, Inc., SMITH & NEPHEW INC., SMITH & NEPHEW, INC. |
| Establishment registrations | 1020279, 1643264, 3007366790, 3038503932 |
| FEI numbers | 1020279, 1643264, 3007282753, 3038503932 |
| Establishment operations | Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 10–99 UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database